Z-2719-2016Class II

ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in...

Name: Z-2719-2016 ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in...
Creator: Advanced Medical Solutions Ltd.
Published: 2015-01-15
License: https://open.fda.gov/license/

Advanced Medical Solutions Limited / initiated 2015-01-15 / Terminated / root cause: packaging

FDA source

Advanced Medical Solutions Ltd. began a recall of ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple... on 2015-01-15. FDA classified it as Class II and gives the reason as "On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2719-2016
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Posted: 2016-09-02
Terminated: 2016-11-23
Recalling firm: Advanced Medical Solutions Limited
Product: ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
Product code: FRO Dressing, Wound, Drug
Reason for recall: On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
Quantity in commerce: 47,569 cartons
Distribution: OH
Product codes and lots: AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213 53488 53532 53628 53665 53633 53981 53989 54066 01334 01263 01341 02112 02438 02583 02592 02582 02523 03138 03667 03675 03819 03908 03779 04254 04142 05996 06086 06256

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2719-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2719-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02
Z-2720-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code FRO

K090453UnclassifiedSilver Alginate 11 Wound DressingAdvanced Medical Solutions Limited / cleared 2009-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)